The VENX REVOLUTION™ is a sterile, disposable, single patient use surgical instrument for the disruption and destruction of spider veins located in the lower extremities of the body. The device is made available in several sizes to accommodate a range of veins that form in the lower body. The VENX REVOLUTION™ consists of a thermoplastic handle containing a lever actuated rack and gear mechanism for rotating a shaft extending from the handle. At the end of the shaft are stainless steel, needle-like tines sharpened and spaced appropriately to straddle veins located just below the surface of the skin. Once the tines are in place straddling the vein, the levers are actuated causing the shaft to rotate approximately 360° or more. Actuating the levers causes internal springs to compress. Once the levers have rotated the shaft 360° and the tines have disrupted the vein, releasing the levers allows the compressed springs to return the tines to their original position. The device is then withdrawn and re-inserted at another position within the clinician-selected area to repeat the operation on the same vein or on another vein. The procedure is repeated until all veins within the selected area have been treated.

AI/ML Overview

The VENX REVOLUTION is a manual surgical instrument for the disruption and destruction of spider veins in the lower extremities. The device incorporates a lever-actuated mechanism to rotate tines a minimum of 360 degrees.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study Supporting Performance
Functional Equivalence	Ability to disrupt and destruct spider veins	Performed as intended and equivalent to the predicate device	Bench testing under simulated actual use conditions
Device Integrity/Durability	Tine deformation	Not explicitly detailed as a separate criterion, but included in "Testing"	Bench testing
Device Functionality	Cycle life	Not explicitly detailed as a separate criterion, but included in "Testing"	Bench testing
Mechanical Operation	Rotating mechanism operation	Not explicitly detailed as a separate criterion, but included in "Testing"	Bench testing

2. Sample size used for the test set and the data provenance:

The provided document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing described is "Bench testing... using simulated actual use conditions," which suggests in-vitro testing rather than human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not mention the use of experts to establish ground truth for the test set. The evaluation was done through "Bench testing," likely involving engineering and technical assessment rather than clinical expert consensus.

4. Adjudication method for the test set:

No adjudication method is mentioned as there were no human subjects or expert assessments involved in the "Bench testing."

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. The testing described is bench testing, not a clinical study involving human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The concept of "standalone performance" typically applies to AI algorithms. Since this is a manual surgical instrument, this question is not directly applicable. The device itself is a "standalone" mechanical tool, and its performance was assessed in isolation through bench testing.

7. The type of ground truth used:

Given that the study involved "Bench testing using simulated actual use conditions," the "ground truth" would likely be based on physical measurements and engineering specifications related to the device's ability to disrupt simulated veins and its mechanical integrity, rather than expert consensus, pathology, or outcomes data from human subjects. For example, successful disruption of a simulated vein might have been a measurable outcome against a predefined physical standard.

8. The sample size for the training set:

There is no training set as this is a mechanical device undergoing bench testing, not an AI or algorithmic system that requires training data.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this type of device and study.

Summary

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K110355
510(k) Summary

VENX LLC 510(k) Notification Submission

APR 2 2 2011

Date: January 31, 2011

Submitted by: VENX LLC 2701 NW 2nd Avenue, Suite 218 Boca Raton, FL 33431

561-237-5008 Phone: 561-237-5040 Fax:

Contact: Navroze Mehta

Manual Surgical Instrument

Common Name: Manual Surgical Instrument

Trade Name: VENX REVOLUTION™

Classification Name:

Classification: Class I per 21 CFR 878.4800

Predicate Device: Advanced Medical Products, Arachnophlebectomy Needle (K000932)

Description:

Intended Use:

The VENX REVOLUTION™ is a manual surgical instrument intended for use in the destruction of spider veins in the lower extremities of the body.

Comparison to Predicate Devices:

The VENX REVOLUTION™ differs from the predicate device only in the mechanism for rotating the device tines. The predicate device relied on the clinician to manually rotate the pen-like device within the fingers to disrupt the vein. The VENX REVOLUTION™™

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110355

Page 2 of 2

VENX LLC
510(k) Notification Submission

incorporates a lever-actuated mechanism to rotate the tines a minimum 360° by actuating levers with the fingers. The basic construction, and available sizes of the tines remain unchanged.

Testing:

Bench testing has been conducted using simulated actual use conditions comparing the new device and its ability to disrupt and destruct spider veins to that of the predicate device. The results of the testing show the new device to perform as intended and equivalent to the predicate device. Testing included tine deformation, cycle life, and rotating mechanism operation.

Conclusion:

In accordance with the Food, Drug, and Cosmetic Act and 21 CFR 807, and based on the information provided in the premarket notification, VENX LLC concludes that the VENX REVOLUTION™ is safe, effective and substantially equivalent to the predicate device discussed herein.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Venx. ILC % MRI Medical Mr. Ira Duesler 4700 S. Overland Drive Tucson, Arizona 85714

APR 2 2 2011

Re: K110355 Trade Name: Venx Revolution™ Classification Regulation Name and Number: Manual Surgical Instrument for General Use,

21 CFR 878.4800

Regulatory Class: Class I Exempt Product Code: 79 GAH (Stylet, Surgical, General & Plastic Surgery) Dated: January 31, 2011 Received: February 7, 2011

Dear: Mr. Duesler

We have reviewed your premarket notification submission and have found this device to be exempt from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (Act). Therefore, you may immediately begin marketing this device as described in your premarket notification.

The final classification regulation for your device appears in Title 21 of the Code of Federal Regulations (CFR) 878.4800. We suggest that you review this regulation since it may grant other exemptions from certain general controls of the Act. Your device classification regulation name, regulatory class, and product code are shown above. When listing your device with the Food and Drug Administration, please use this product code.

In the future, new but substantially equivalent devices which fall within the above classification regulation name and meet the classification criteria may be marketed without sending a premarket notification submission to the Food and Drug Administration. We suggest, however, that you review 21 CFR Section 878.9 to determine whether or not your new device meets the limitations of exemption from Section 510(k) of the Act.

If you have any questions regarding this letter, please contact George J.Mattamal, Ph.D at (301) 796-6396 or the Division of Small Manufacturers, International and Consumer Assistance at its

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Page 2 - Mr. Ira Duesler

toll free number (800) 638-2041 or (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely yours,

A.J. B. n h
fer

Mark N. Melkerson Director Division of Surgical, Orthopedic and Reconstructive Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications For Use

510(k) Number (if known): K110355

Device Name: VENX REVOLUTION™

Indications For Use:

The VENX REVOLUTION™ is a manual surgical instrument intended for use in the destruction of spider veins in the lower extremities of the body.

Prescription Device × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nel R.P. Ayde firmen
(Division Sign Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110355

Regulation Number and Section

§ 878.4800 Manual surgical instrument for general use.

(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.